"Attention Researchers: Grant Money Available!"

This is the headline for a web page recently posted by the Agency for Health Care Policy and Research. The coming year is the first in a long while that this agency has received its full requested funding from Congress. AHCPR had come under political fire several years back for its funding of studies which called into question the efficacy of some established medical treatments. In a classic case of shooting the messenger, professional and advocacy groups with vested interests in some of these treatment approaches pressured Congress to cut back AHCPR funding, and even threatened its existence. The Congressional turnaround in funding for AHCPR may reflect a new acceptance of the need to rigorously and critically examine the way health care is delivered. 

AHCPR's Fiscal Year 1999 budget of $171.055 million will allow the Agency to double the amount it awarded last year for investigator-initiated grants and to pursue critical national priorities, including research on quality and outcomes. The amount awarded will increase from $8 million to $16 million. AHCPR is looking for outstanding proposals that advance these priorities: 
 
 
 
 

* Outcomes for the Elderly and Chronically Ill. 
* Clinical Preventive Services. 
* Centers for Education and Research's Therapeutics. 
* Improving the Quality of Children's Health. 
* Pharmaceutical Outcomes Research. 
* Evidence-based Practice. 
* Primary Care Research. 
* Shared Decisionmaking. 
* Consumer Decisionmaking. 
* Access, Costs, Quality, and Outcomes. 
* Quality Measurement and Improvement. 
* Health Care Financing and Organization. 

AHCPR is looking for proposals that put a special focus on the needs of vulnerable populations and that promote partnerships with potential users of the research findings, such as managed care organizations, primary care organizations, and health care systems to speed the translation of research into practice. 

Several ongoing program announcements are available from AHCPR. These opportunities may be applied for under three deadlines each year until further notice: 

 
Measures of Quality of Care for Vulnerable Populations 
Cancer Surveillance Using Health Claims-Based Data System 
Economic Studies in Cancer Prevention, Screening, and Care 
Economic Evaluation in HIV and Mental Disorders Prevention 
AHCPR Health Services Research Program Announcement 
Effectiveness of Children's Mental Health and Substance Abuse Treatment in the General Health Sector 
AHCPR Small Project Grant Program 
Small Grant Program for Conference Support

In addition, on December 24, the agency announced its priorities for expanded investigator-initiated research funding. This special program emphasis invites projects that will: 

 
o focus on the relationship between processes and outcomes of care for older populations with one or more chronic conditions; and/or 

o clarify which are the most effective interventions or components of programs intended to improve functional outcomes or prevent deterioration in functional status in older people with chronic illness; and/or 

o assess the effect of co-existing illness on clinical management, patient decision-making and preferences for care, and health outcomes; and/or 

o clarify the comparative effectiveness and cost-effectiveness of alternative strategies, with a specific focus on combined clinical and organizational interventions such as disease-management programs, patient self-management programs, group visits, and efforts led by multidisciplinary teams, to improve outcomes in older people with chronic conditions. 
 

A copy of the complete AHCPR announcement on investigator-initiated research may also be obtained from the Office of Research Development or at the web site noted above. 
 

In November the Food and Drug Administration issued new "Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators", which describe the agency's expectations for carrying out FDA-regulated activities. One question answered in the Information Sheets is how an investigational drug or device may be used for treatment purposes, outside a clinical trial. A number of limitations and expectations are connected with such use. Physicians who may wish to use investigational drugs for treatment should be familiar with them. 

First, all use of investigational new drugs or devices, for clinical or research purposes, requires both IRB approval and informed consent. In very critical situations, both the requirement for prior IRB review and informed consent may be waived, provided the conditions described below are met. 
 

Emergency Use Without Prior IRB Approval

The FDA recognizes that treatment decisions may be made outside of research considerations. Physicians retain the authority to provide emergency medical care to their patients without prior Scientific Committee approval. However, in these cases, physicians must meet FDA requirements to use investigational articles for emergency purposes. 

An Emergency IND Request allows the use of an investigational article outside an approved clinical protocol and without prior Scientific Committee approval in emergency situations. These are defined as: 

• life-threatening situations 
• in which no standard acceptable treatment is available and 
• there is not sufficient time to obtain prospective Scientific Committee approval for use. 

In all but the most acute life-threatening situations, the investigator is required to obtain prior verbal approval of the Chair or Co-Chair of the Scientific Committee. Patients offered investigational drugs on an emergency basis must give informed consent. Limited exceptions to this consent requirement are described below. 

For the purposes of using investigational drugs for emergency treatment, the term "life threatening" includes conditions that are either life threatening or severely debilitating: 

Life threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life threatening do not require the condition to be immediately life-threatening or to immediately result in death. Rather, the patient must be in a life-threatening situation requiring intervention before such intervention can be reviewed at a convened meeting of the IRB. 

Severely debilitating means diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg hand or foot, loss of hearing, paralysis or stroke. 

This exception to prior IRB review may not be used unless all of the conditions described above exist. It allows for one emergency use of a test article. Any subsequent use of the 
investigational product must have prospective IRB review and approval. 

The FDA acknowledges, however, that it would be inappropriate to deny emergency treatment to a second patient if the only obstacle is that the IRB has not had sufficient time to convene a meeting to review the issue. On the other hand, if you have reason to believe that an investigational drug will be appropriate for emergency treatment of multiple patients, you should develop a protocol for its use and seek prospective IRB approval. 

Within 5 days of the emergency drug use, the physician must make a report in writing to the IRB for review and consideration at its next convened meeting. This report should detail: 

 
1) the rationale for using the investigational item, including any evidence from prior studies that the agent might be safe and effective for the condition being treated; 
2) the clinical context for its use, especially addressing the threat to the patient and the lack or ineffectiveness of approved alternative treatments; 
3) if available, the FDA IND number for this agent and a copy of any ongoing protocol for its use. 

Approval of the emergency drug request is not complete until given by the full IRB. 

Note that patients treated under an Emergency IND Request may not be entered as subjects in a research project or clinical trial. 

Obtaining an Emergency IND

The emergency use of an unapproved investigational drug or biologic also requires Investigational New Drug (IND) status from the FDA. If the patient does not meet the criteria of an existing study protocol, or if an approved study protocol does not exist, the usual procedure is to contact the manufacturer and determine if the drug or biologic can be made available for the emergency use under the company's IND. 

The need for an investigational drug or biologic may arise in an emergency situation that does not allow time for submission of an IND. In such a case, FDA may authorize shipment of the test article in advance of the IND submission. Requests for such authorization may be made by telephone: 

FDA Contacts for Emergency Drug Shipment

 
1. For drug products contact: 
Document Requirements andServices Branch (HFD-53) (301) 827-1501 

2. For biologic products contact: Division of Congressional and Public Affairs (HFM-11) 
(800) 835-4709 

3. Nights and weekends contact: 
: Division of Emergency and Epidemiological Operations(HFC-160) (202) 857-8400 
 

All effort should be made to obtain informed consent from the patient or the patient's legal representative before using an investigational drug for emergency treatment. In cases where this is not possible, both the treating physician and another physician not involved in any trial of the test article must certify in writing that all four of the following apply: 

 
1. The patient is confronted by a life-threatening situation necessitating the use of the test article. 
2. Informed consent cannot be obtained because of an inability to communicate with, or obtain legally effective consent from, the patient. 
3. Time is not sufficient to obtain consent from the patient's legal representative. 
4. No alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the patient's life. This written certification should be submitted to the IRB within 5 days as part of the Emergency IND Request. 

Non-Emergency Treatment Uses of Investigational Drugs

Investigational products are sometimes used for treatment of serious or life-threatening conditions either for a single subject or for a group of subjects. The following mechanisms expand access to promising therapeutic agents without compromising the protection afforded to human subjects or the thoroughness and scientific integrity of product development and marketing approval. 

Open Label Protocol or Open Protocol IND

These are usually uncontrolled studies, carried out to obtain additional safety data (Phase 3 studies). They are typically used when the controlled trial has ended and treatment is continued so that the subjects and the controls may continue to receive the benefits of the investigational drug until marketing approval is obtained. These studies require prospective Institutional Review Board (IRB) review and informed consent. 

Treatment IND

With a Treatment IND you may treat eligible subjects with investigational drugs for serious and life-threatening illnesses for which there are no satisfactory alternative treatments. A treatment IND may be granted after sufficient data have been collected to show that the drug may be effective and does not have unreasonable risks. Because data related to safety and side 
effects are collected, treatment INDs also serve to expand the body of knowledge about the drug. 

There are four requirements that must be met before a treatment IND can be issued: 

1) the drug is intended to treat a serious or immediately life-threatening disease; 
2) there is no satisfactory alternative treatment available; 
3) the drug is already under investigation, or trials have been completed; and 
4) the trial sponsor is actively pursuing marketing approval.

Group C Treatment IND

The "Group C" treatment IND was established by agreement between FDA and the National Cancer Institute (NCI). The Group C program is a means for the compassionate distribution of investigational agents to oncologists for the treatment of cancer under protocols outside the controlled clinical trial. Group C drugs are generally Phase 3 study drugs that have shown evidence of relative and reproducible efficacy in a specific tumor type. They can generally be administered by properly trained physicians without the need for specialized supportive care facilities. Group C drugs are distributed only by the National Institutes of Health under NCI protocols. Although treatment is the primary objective and patients treated under Group C guidelines are not part of a clinical trial, safety and effectiveness data are collected. Although the FDA does not require local IRB review of Group C protocols, Cook County Hospital requires prior review and approval, as well as informed consent by the patient. 

Parallel Track

The Parallel Track permits wider access to promising new drugs for AIDS and HIV-related diseases under a separate "treatment" protocol that "parallels" the controlled clinical trials that are essential to establish the safety and effectiveness of new drugs. It provides an administrative system that expands the availability of drugs for treating acquired immunodeficiency syndrome (AIDS) and other HIV- related diseases. These studies require prospective IRB review and informed consent. 

Off-label Use of Approved Drugs

At Cook County Hospital, treatment use of approved drugs for non-FDA approved indications may also be subject to prior approval by the Chair of the Scientific Committee. This is a hospital requirement, not mandated by the FDA. 

If the drug appears on the list of drugs with prior approval for this indication maintained by the Drug and Formulary Committee, a physician may order the drug under his/her license. If the drug has not received such prior approval, then approval by the Scientific Committee Chair is required before use. A written request must be made, giving the rationale and clinical context for this use. Note that off-label use of approved drugs does not require that the patient's condition be life-threatening, while emergency use of investigational drugs does have this requirement. As with the Emergency IND Request, an Off-Label Request may be approved verbally by the Chair if the situation demands, to be followed within 5 days by a written report 

To obtain a copy of the updated FDA Information Sheets contact: 

Food and Drug Administration 
Office of the Associate Commissioner for Health Affairs 
5600 Fishers Lane 
Rockville, MD 20857 
301-827-1685 

An older version of this document can be found online at 
http://www.fda.gov/oc/oha/IRB/toc.html

The 1999 Conference on Substance Abuse Prevention sponsored by the Illinois Department of Human Services, the State Board of Education and Prevention First, Inc., invites abstracts on methodologies for implementing, developing and providing effective substance abuse prevention programming. Deadline for abstracts is January 12. The conference will take place in Chicago April 7-8, 1999. Abstract forms are available from the Office of Research Development, or call 800-252-8951. 
 

[A long-term calendar showing most of the major academic medical society meetings can be found on the web at: http://www.aamc.org/meetings/mjmtgcal.htm] 

Regional Conference on Dually Diagnosed Adolescents, sponsored by the Mayor's Office of Substance Abuse Policy, will be held in Chicago May 3 and 4. Call 312-747-2606 for information. 

Donor's Forum of Chicago Programs: 
The Donor's Forum is a local resource for private foundations and those who seek funding from them. It is located at 208 South LaSalle, 
Suite 740, Chicago. The phone number is 
312-578-0090 

The Donor's Forum maintains a library of information about private funding opportunities in the Chicago region. It also publishes a directory of Illinois Foundations, a copy of which can be found in the Research Development Resource Room, 603 Durand. Some upcoming programs offered by the Donor's Forum are: 

The ABC's of Proposal Preparation & Writing: Two-day sessions will be offered Feb 25-26, March 22-23, April 20-21 and May 20-21 
Major Gift and Capital Campaign Fundraising: One-day sessions will be held April 27 and June 29. 
Securing Support from Individuals: One-day sessions on March 5 and May 28 
Outcome Evaluation for Nonprofit Organizations: One-day sessions January 28, March 25 and June 9. 

Discussions with Donors: 
Introduction to Principles for Community Health Care, January 27 
A Special Focus on Family Foundations, February 23 
 

Office of Research Development Workshops 

These workshops are open to any County-affiliated investigator or grant-seeker. Enrollment for some sessions is limited, so please register only for those you will be able to attend. 

Grant Writing Seminar:

Gives an overview of the entire process of developing a project and applying for funding. Includes information on approaching both governmental and private funders, describes an approach to developing grant budgets, discusses stylistic and content issues that are frequent stumbling blocks in writing grant applications.

Constructing a Grant Budget:

Covers many of the technical aspects of developing an accurate time line and budget for a grant proposal.

What Are All These Forms? Interacting With the Scientific Committee: 

Gives an orientation to procedures -- and the associated forms -- used by the Scientific Committee to 
ensure that patients are protected from undue risks in research. The Bureau forms will be discussed, and new policies and changes in federal regulations will be covered.

To register for any of these, call Bennetta Anderson at 312-633-4941. If you would like to schedule one or more of these workshops in your Department or at another site, please call Karen Smith at 633-4940. 
 
 

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To have the NIH Guide sent automatically to your e-mail address every week, click on the LISTSERV link on this page and follow the instructions.

To ask specific questions about NIH grant programs, send e-mail to: grantsinfo@nih.gov 
 

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These are one time only opportunities. Call 312-633-4940 to check for due dates or to get copies of full announcements
 
 

EARLY ACCESS TO DEFIBRILLATION FOR VICTIMS OF OUT-OF-HOSPITAL CARDIAC 
ARREST (OOH CA) (BAA NHLBI-HC-99-06) 
National Heart, Lung and Blood Institute 

INSULATING BIOMATERIALS (RFP NIH-NINDS-99-04) National Institute of Neurological Disorders and Stroke 

POLYCYSTIC KIDNEY DISEASE: INNOVATIVE IMAGING TO ASSESS PROGRESSION (RFA DK-99-003) National Institute of Diabetes and Digestive and Kidney Diseases 

DEVELOPMENT OF ASSAY METHODS FOR CREUTZFELDT-JAKOB DISEASE (CJD) 
(RFA HL-99-003) National Heart, Lung, and Blood Institute 

NINR MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD FOR MINORITY 
INVESTIGATORS (RFA NR-99-003) 
National Institute of Nursing Research 

EVOLUTION OF INFECTIOUS DISEASES 
(RFA GM-99-005) National Institute of General Medical Sciences; National Institute of Allergy and Infectious Diseases 

PHENOTYPIC CHARACTERIZATION OF SLEEP IN MICE (RFA HL-99-001) National Heart, Lung, and Blood Institute, National Institute on Mental Health, National Institute on Aging, National Institute of Neurological Disorders and Stroke 

BRINGING DRUG ABUSE TREATMENT FROM RESEARCH TO PRACTICE (RFA DA-99-007) National Institute on Drug Abuse 

RESEARCH ON DRUG COURTS (RFA DA-99-008) National Institute on Drug Abuse 

BEHAVIORAL THERAPY DEVELOPMENT AND BEHAVIORAL SCIENCE (RFA DA-99-009) National Institute on Drug Abuse 

MEASURES OF QUALITY OF CARE FOR VULNERABLE POPULATIONS (RFA HS-99-001) Agency for Health Care Policy and Research 

NEUROLOGICAL COMPLICATIONS OF DIABETES (RFA NS-99-005) National Institute of Neurological Disorders and Stroke, National Institute of Diabetes and Digestive and Kidney Diseases 

DIABETES CENTERS OF EXCELLENCE 
(RFA DK-99-002) National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Allergy and Infectious Diseases, 
Juvenile Diabetes Foundation International

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NIH PROGRAM ANNOUNCEMENTS 
(PA'S): These are ongoing funding priorities, with due dates usually October 1, February 1 and June 1 of each year. Note that HIV-related applications are due January 2, May 1 and September. Past PA's, many of which are still open, can be searched at the NIH Guide web site.
 

COPING WITH AIDS AS A CHRONIC LONG-TERM ILLNESS (PA-99-026) National Institute of Mental Health, National Institute on Drug Abuse, National Institute of Nursing Research 

MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD IN MOLECULAR EPIDEMIOLOGY (PAR-99-027) National Institute of Environmental Health Sciences 

HIV-AIDS AND RELATED ILLNESSES RESEARCH COLLABORATION (PA-99-029) 
Fogarty International Center 

AGING AND OLD AGE AS RISK FACTORS FOR MULTIPLE PRIMARY TUMORS (PA-99-030) National Institute on Aging, National Institute of Dental and Craniofacial Research 

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February 16 
ENVIRONMENTAL RADIATION STUDIES, Centers for Disease Control and Prevention (888-472-6874, refer to announcement 99020, or http://www.cdc.gov) 

February 15 
EMERGING INFECTIONS SENTINEL NETWORKS, Centers for Disease Control and Prevention (888-472-6874, refer to announcement 99025, or http://www.cdc.gov) 

March 5 (preapplication) 
ENVIRONMENTAL JUSTICE SMALL GRANTS PROGRAM, Environmental Protection Agency (202-564-2594, refer to CFDA 66.604, or http://es.epa.gov/oeca/oej/grlink1.html) 

January 15 
BREAST CANCER SCREENING, Avon Breast Health Access Fund (212-889-0606, x 3004, or http://www.nabcp.org) 

March 1 
EDUCATION PROJECTS FOR GIFTED CHILDREN OR CHILDREN WITH DISABILITIES, Foundation for Exceptional Children (703-264-3507 or http://www.cec.sped.org/fd/minigapp.htm

The Office of Research Development and the Scientific Committee exist to help you carry out research and grant-funded programs. Part of this mission is to provide the information, support and materials you may need. Another part is to keep you informed about institutional and regulatory expectations about grants and research and to help you meet those expectations. 

We would very much like to hear about how well we have accomplished our aims in these areas. If you have feedback you would like to give about your interactions with us, please fill out this form, and send or deliver it to Hektoen Room 277, or call the Director, Karen Smith, at 312-633-4940, or email at kmsmith@wwa.com. 

In your contact with the Office of Research Development/Scientific Committee: 
 

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If the person you spoke to could not answer your question, were you referred to someone who could? 
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